Insertion device for an insertion set and method of using the same

ABSTRACT

An insertion device and insertion set. The insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient includes a device housing, a carrier body and a driver. The carrier body is slidably received within the device housing for movement between an advanced position and a retracted position. The carrier body also includes a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position. The driver is operatively coupled between the device housing and the carrier body to urge the carrier body with a controlled force and speed from the retracted position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set thorough the skin of the patient to install the insertion set to the patient. The receiving structure of the carrier body is removable from the insertion set while maintaining the installation of the insertion set to the patient.

RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 09/002,303, filed Dec. 31, 1997, which is hereinspecifically incorporated by reference.

FIELD OF THE INVENTION

[0002] This invention relates generally to an insertion device forautomatic placement of an insertion set through the skin of a patient,and in particular embodiments to a compact and easily operated insertiondevice for placement of an insertion needle of a subcutaneous insertionset or the like through the skin of a patient with a controlled forceand insertion speed by the patient.

BACKGROUND OF THE INVENTION

[0003] Medical needles are widely used in the course of patient care andtreatment, particularly with respect to the delivery of selectedmedications to a patient. In one common form, hollow hypodermic needlesare employed for transcutaneous delivery of a selected medication from asyringe or the like. In another common form, insertion needles areemployed for transcutaneous placement of a soft and relatively flexibletubular cannula, followed by insertion needle removal and subsequentinfusion of medical fluid to the patient through the cannula. Morerecently, insertion needles have also been used for transcutaneouslyplacing other medical devices such as a subcutaneous sensor formonitoring specified patient parameters, such as blood glucose level.

[0004] In certain medical treatment regimens, it may be necessary ordesirable for the patient to transcutaneously place the medical needle.For example, diabetic patients frequently self- administer insulininjections or periodically place a subcutaneous insertion with a cannulafor subsequent programmable delivery of insulin by means of a medicationinfusion pump of the general type described in U.S. Pat. No. 4,685,903.Such subcutaneous insertion sets are disclosed, for example, in U.S.Pat. Nos. 4,755,173; 5,176,662; and 5,257,980 which are incorporated byreference herein. Diabetic patients may also use a subcutaneousinsertion set to periodically place a transcutaneous glucose sensorwherein such sensor insertion sets are disclosed, for example, In U.S.Pat. Nos. 5,390,674; 5,568,806; 5,586,553, which are also incorporatedby reference herein.

[0005] Some patients are reluctant or hesitant to pierce their own skinwith a medical needle, and thus encounter difficulties in correct needleplacement for proper administration of the medication. Such difficultiescan be attributable to insufficient manual dexterity or skill to achieveproper needle placement or, alternately to, anxiety associated withanticipated discomfort as the needle pierces the skin. This problem canbe especially significant with medications delivered via a subcutaneousflexible insertion set, since incorrect placement can cause kinking ofthe cannula and resultant obstruction of medication flow to the patient.Cannula kinking can be due to insertion set placement at an incorrectangle relative to the patient's skin, and/or needle placement with anincorrect force and speed of insertion.

[0006] The present invention relates to an automatic injector,particularly for use with a subcutaneous insertion set, for quickly andeasily placing an insertion needle through the skin of a patient at thecorrect insertion angle, and with a speed and force of insertion whichminimizes patient discomfort.

SUMMARY OF THE DISCLOSURE

[0007] It is an object of an embodiment of the present invention toprovide an improved insertion device and insertion set, which obviatesfor practical purposes, the above mentioned limitations.

[0008] According to an embodiment of the invention, an injector isprovided for quick and easy transcutaneous placement of a medical needlethrough the skin of a patient, particularly such as an insertion of asubcutaneous insertion set. The injector is designed to place the needlethrough the skin at a selected insertion angle and with a controlledforce and speed of insertion, to ensure proper needle placement withminimal patient discomfort. The injector is particularly designed tomeet these objectives, while safeguarding against undesired projectionof the medical needle through free space, in the event that the injectoris actuated in spaced relation to the patient's skin.

[0009] The injector comprises a spring-loaded plunger having a head forreceiving and supporting an insertion set in a position with aninsertion projecting outwardly for transcutaneous placement through theskin of a patient. The plunger is designed for retraction and retentionwithin a barrel to a cocked position with a drive spring compressed in amanner applying a predetermined spring force to the plunger head. Afront or nose end of the injector barrel is designed for pressedplacement against the skin of a patient, at a selected needle insertionsite, and in an orientation with the needle disposed at a correct ordesired insertion angle. A trigger member is operable to release theplunger and thereby permit the drive spring to carry the insertion settoward the patient's skin with a controlled force and speed, resultingin proper transcutaneous placement of the insertion needle with minimalpatient discomfort.

[0010] The plunger head includes a safety lock mechanism to retain theinsertion set against projection from the injector barrel. In onepreferred form, the safety lock mechanism comprises at least one andpreferably a pair of safety lock arms for engaging and retaining theinsertion set when the plunger is retracted from a fully advancedposition. Each safety lock arm includes a cam lobe for engaging anappropriately shaped recess on the insertion set to prevent releasethereof from the plunger head, unless and until the plunger head isreturned to the fully advanced position. In such fully advancedposition, the shape of the cam lobe permits quick and easy separation ofthe injector from the insertion set with a minimal separation force.

[0011] In operation, the safety lock arms thus prevent projection of theinsertion set from the injector, in the event that the trigger member isactuated with the nose end of the barrel spaced from the skin of apatient. In that event, the plunger head is advanced with the controlledforce and speed to the filly advanced position, but the insertion set isnot thrown from the injector as a projectile. Instead, the insertion settravels rapidly with the plunger head to the fully advanced position,whereat the injector can be separated with minimal separation force fromthe insertion set.

[0012] In an alternative preferred form, the safety lock mechanismcomprises a plunger head having a cylindrical shape defining a forwardlyopen cavity for receiving and supporting an insertion set with theinsertion needle and cannula projecting outwardly. In this embodiment,the plunger head includes a radially inwardly projecting rim at aforward or nose end thereof, wherein the rim defines an oval-shapedopening. The size of the rim opening permits relatively free receptionof a hub on the insertion set, with the infusion set oriented at anangle relative to a central axis of the plunger head and barrel. Theinsertion set is then reoriented to align the insertion needle coaxiallywith the central axis of the barrel and plunger head, so that the rim isreceived into a recess on the insertion set and functions to retain theinfusion set against undesired release from the injector duringspring-driven placement of the needle. After needle placement, theinjector is released from the insertion set with minimal separationforce by orienting the injector angularly relative to the insertion setto permit free slide out passage of the hub through the oval rimopening.

[0013] In a further alternative form of the invention, the plunger headis shaped to define a laterally open undercut slot sized for relativelyfree slide-fit reception of the needle hub of the insertion set. In thisversion, the insertion set is assembled quickly and easily with theplunger head of the injector by laterally sliding the hub into thelaterally open slot, thereby orienting the medical needle generallycoaxially relative to the central axis of the injector barrel andplunger head. In this position, the plunger head can be retracted andlocked, followed by appropriate trigger member release fortranscutaneously placing the medical insertion needle. After the needleis placed on the patient, the injector can be disassembled from theinsertion set by laterally sliding the injector relative to the needlehub. Alternatively, the injector can be withdrawn or retracted from thepatient's skin to slidably separate the needle from the insertion setwhich remains in place on the patient's skin.

[0014] In other embodiments of the present invention, an insertiondevice for inserting at least a portion of at least one piercing memberof an insertion set through the skin of a patient includes a devicehousing, a carrier body and a driver. The carrier body is slidablyreceived within the device housing for movement between an advancedposition and a retracted position. The carrier body also includes areceiving structure to support the insertion set in a position with theat least one piercing member oriented for insertion through the skin ofthe patient at a predetermined angle relative to the skin of the patientupon movement of the carrier body from the retracted position to theadvanced position. The driver is operatively coupled between the devicehousing and the carrier body to urge the carrier body with a controlledforce and speed from the retracted position toward the advanced positionto place at least a portion of the at least one piercing member of theinsertion set thorough the skin of the patient to install the insertionset to the patient. The receiving structure of the carrier body isremovable from the insertion set while maintaining the installation ofthe insertion set to the patient.

[0015] In particular embodiments, the predetermined angle relative tothe skin is about 90 degrees, between 90 degrees and 10 degrees, or isafter insertion between 0 and 10 degrees. In additional embodiments, theinsertion set is a transuctaneous insertion set, a subcutaneousinsertion set, an infusion set, sensor set or the like. In still otherembodiments, the insertion set rests mainly on the surface of the skinafter insertion or the insertion set is implanted in the skin of thepatient. In preferred embodiments, the at least one piercing member is aneedle. In alternative embodiments, the at least one piercing member isa plurality of needles, and can also be a plurality of micro-needles.Also, in some embodiments, the insertion set insertion set can be bothan infusion set and a sensor set combined into an integral unit.

[0016] In yet other embodiments the insertion device, the device housinghas a forward end defining a generally planar angled insertion contactsurface for placement against the skin of a patient with the devicehousing in a predetermined orientation relative to the patient's skinthat mirrors the predetermined angle relative to the skin of thepatient. Other embodiments include a trigger mechanism that actuates thedriver. For instance, the trigger mechanism includes at least onetrigger for fingertip depression to actuate the driver for movement ofthe carrier body from the retracted position to the advanced position.In addition, the driver can include at least one spring forspring-loaded movement of the carrier body from the retracted positionto the advanced position. Further, the driver can include a forcechanging mechanism that permits alteration of the controlled force andspeed of the carrier body moving from the retracted position to theadvanced position from one insertion cycle to another insertion cycle.In still further embodiments, the device housing and the carrier bodyinclude a cooperatively engageable track mechanism for guiding movementof the carrier body between the advanced and retracted positions whileretaining the carrier body against rotation relative to the devicehousing.

[0017] In additional embodiments of the insertion device, the at leastone piercing member is provided with a piercing member hub as part ofthe insertion set. In addition, the receiving structure of the carrierbody includes a recess formed therein for mated slide-fit reception ofthe piercing member hub of the insertion set. Further, the recess of thereceiving structure can include a laterally open undercut recess.Alternatively, the receiving structure may include a safety retainerstructure that retains the at least one piercing member on the receivingstructure during movement from the retracted position to the advancedposition. This safety retainer structure permits separation of the atleast one piercing member from the carrier body when the carrier body isin the advanced position.

[0018] Yet another embodiment of the present invention is directed to aninsertion set for insertion through the skin of a patient by aninsertion device. The insertion device has a slidable carrier body formovement between an advanced position and a retracted position. Thecarrier body of the insertion device including a receiving structure tosupport the insertion set in a position for insertion through the skinof the patient upon movement of the carrier body from the retractedposition to the advanced position. The insertion device also having adriver operatively coupled to the carrier body that urges the carrierbody with a controlled force and speed from the retracted positiontoward the advanced position for insertion of the insertion set thoroughthe skin of the patient. The insertion set includes at least onepiercing member and a set housing. The at least one piercing memberincludes a portion of the at least one piercing member that isinsertable through the skin of the patient. The set housing is coupledto the at least one piercing member. Also, the set housing is shaped tofit within the carrier body of the insertion device to orient the atleast one piercing member for placement through the skin of the patientof at least a portion of the at least one piercing member at apredetermined angle relative to the skin of the patient to install theinsertion set to the patient. The set housing of the insertion set isremovable from the receiving structure of the carrier body whilemaintaining the installation of the insertion set to the patient.

[0019] In particular embodiments of the insertion set, the predeterminedangle relative to the skin is about 90 degrees, between 90 degrees and10 degrees, or is after insertion between 0 and 10 degrees. Inadditional embodiments, the insertion set is a transuctaneous insertionset, a subcutaneous insertion set, an infusion set, sensor set or thelike. In still other embodiments, the insertion set rests mainly on thesurface of the skin after insertion or the insertion set is implanted inthe skin of the patient. In preferred embodiments, the at least onepiercing member is a needle. In alternative embodiments, the at leastone piercing member is a plurality of needles, and can also be aplurality of micro-needles. Also, in some embodiments, the insertion setcan be both an infusion set and a sensor set combined into an integralunit.

[0020] Other features and advantages of the invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings which illustrate, by way of example,various features of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] A detailed description of embodiments of the invention will bemade with reference to the accompanying drawings, wherein like numeralsdesignate corresponding parts in the several figures.

[0022]FIG. 1 is a perspective view illustrating use of an automaticinjector embodying the novel features of the invention;

[0023]FIG. 2 is an enlarged front elevation view of the injector shownin FIG. 1;

[0024]FIG. 3 is a front or nose end view of the injector, takengenerally on the line 3-3 of FIG. 2;

[0025]FIG. 4 is an enlarged exploded perspective view illustratingassembly of the injector with a subcutaneous insertion set;

[0026]FIG. 5 is a further enlarged longitudinal sectional view takengenerally on the line 5-5 of FIG. 4;

[0027]FIG. 6 is a transverse sectional view taken generally on the line6-6 of FIG. 5;

[0028]FIG. 7 is an enlarged longitudinal sectional view taken generallyon the line 7-7 of FIG. 2;

[0029]FIG. 8 is an enlarged and exploded fragmented perspective viewillustrating a trigger assembly for use in the injector;

[0030]FIG. 9 is a longitudinal sectional view similar to FIG. 5, andshowing the injector with insertion set received therein fortranscutaneous placement through the skin of a patient;

[0031]FIG. 10 is a transverse sectional view taken generally on the line10-10 of FIG. 9;

[0032]FIG. 11 is a longitudinal sectional view taken generally on theline 11-11 of FIG. 9;

[0033]FIG. 12 is a rear end elevation view taken generally on the line12-12 of FIG. 1 1, and depicting the trigger assembly in a lockedposition;

[0034]FIG. 13 is an enlarged fragmented longitudinal view similar to aportion of FIG. 11, but depicting actuation of the trigger assembly forreleasing the spring-loaded plunger;

[0035]FIG. 14 is a rear end elevation view taken generally on the line14-14 of FIG. 13, similar to FIG. 12, but showing the trigger assemblyin an unlocked position;

[0036]FIG. 15 is a fragmented longitudinal sectional view depicting thespring-loaded plunger in a fully advanced position with the infusion setplaced on the patient's skin;

[0037]FIG. 16 is an exploded perspective view illustrating separation ofthe insertion needle from the cannula of the subcutaneous insertion set;

[0038]FIG. 17 is a perspective view depicting an alternative preferredform of the invention;

[0039]FIG. 18 is a front elevation view of the injector shown in FIG.17;

[0040]FIG. 19 is a front or nose end view of the injector, takengenerally on the line 19-19 of FIG. 18;

[0041]FIG. 20 is an enlarged side elevation view of the injector, takengenerally on the line 20-20 of FIG. 19;

[0042]FIG. 21 is a further enlarged longitudinal sectional view takengenerally on the line 21-21 of FIG. 17;

[0043]FIG. 22 is an enlarged exploded perspective view illustratingconstruction details of a plunger and trigger member for use in theinjector of FIG. 17;

[0044]FIG. 23 is an enlarged longitudinal sectional view similar to FIG.21, and depicting the injector with the trigger member in a cockedposition;

[0045]FIG. 24 is a fragmented perspective view showing the upper end ofthe injector depicted in FIG. 23, with the trigger member in the cockedposition;

[0046]FIG. 25 is an enlarged and fragmented longitudinal sectional viewillustrating actuation of the trigger member;

[0047]FIG. 26 is an enlarged and fragmented longitudinal sectional viewshowing the plunger in a fully advanced position with the infusion setplaced on the patient's skin;

[0048]FIG. 27 is an enlarged fragmented longitudinal sectional viewtaken generally on the line 27-27 of FIG. 22, and depicting a portion ofthe plunger;

[0049]FIG. 28 is a front or nose end elevational view of the plunger,taken generally on the line 28-28 of FIG. 27; and

[0050]FIG. 29 is an enlarged fragmented longitudinal sectional viewillustrating release of the injector from an infusion set placed on thepatient's skin;

[0051]FIG. 30 is an exploded prospective view generally similar to FIG.17, but depicting a further alternative preferred form of the invention,and showing assembly of an insertion set with the illustrative injector;

[0052]FIG. 31 is a perspective view similar to FIG. 32, depictingfurther assembly of the insertion set with the injector;

[0053]FIG. 32 is an enlarged fragmented vertical sectional view takengenerally on the line 32-32 of FIG. 31;

[0054]FIG. 33 is a perspective view showing use of the injector of FIGS.30-32 for transcutaneous placement of the insertion set; and

[0055]FIG. 34 is an exploded perspective view similar to FIG. 33, andshowing use of the injector to separate a medical needle from theinstalled insertion set.

[0056]FIG. 35 is a perspective view of an insertion device with one typeof an insertion set in accordance with a second embodiment of thepresent invention.

[0057]FIG. 36 is a bottom perspective view of the insertion device ofFIG. 35.

[0058]FIG. 37 is a side plan view of the insertion device and insertionset shown in FIG. 35.

[0059]FIG. 38 is an exploded cross-sectional view of the insertiondevice and the one type of insertion set as shown along the line 38-38in FIG. 37.

[0060]FIG. 39 is a top perspective view of one type of insertion set foruse with the insertion device shown in FIG. 35.

[0061]FIGS. 40a-40 g illustrate the steps of inserting the one type ofinsertion set of FIG. 39 with the insertion device of FIG. 35.

[0062]FIG. 41 is a perspective view of an insertion device with one typeof an insertion set in accordance with a third embodiment of the presentinvention.

[0063]FIG. 42 is an exploded perspective view of the insertion deviceshown in FIG. 41.

[0064]FIG. 43 is an exploded side plan view of the insertion device andthe one type of insertion set shown in FIG. 41.

[0065]FIG. 44 is an enlarged side plan view of the one type of insertionset held in a carrier body of the insertion device shown in FIG. 41.

[0066]FIG. 45 is a front perspective view of the insertion device andthe one type of insertion set shown in FIG. 41.

[0067]FIG. 46 is a cross-sectional view of the insertion device and theone type of insertion set as shown along the line 46-46 in FIG. 45.

[0068]FIG. 47 is a top schematic view of an insertion device inaccordance with a fourth embodiment of the present invention.

[0069]FIGS. 48a-48 d are cross-sectional views of a force changingmechanism for use with embodiments of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0070] As shown in the drawings for purposes of illustration, theinvention is embodied in an insertion device for insertion sets such asan infusion set, sensor set, medical device, or the like. Furtherembodiments of the insertion device may be used to insert otherinsertion sets or medical devices such as biodegradable implants,capsules, impregnated threads (with medications or the like). Otherinsertion sets may be directed to a threaded needle insertion set, suchas that described in U.S. Pat. No. 5,584,813 issued Dec. 17, 1996 toLivingston et al. entitled “Subcutaneous Injection Set” and U.S. Pat.No. 5,779,665 issued on Jul. 14, 1998 to Mastrototaro et al. entitled“Transdermal Introducer Assembly”, which are herein incorporated byreference. In addition, the insertion sets may be coated withmedications, or other agents, that inhibit infection and/or promotehealing of the insertion site. Preferred embodiments of the insertiondevice and insertion sets are for transcutaneous placement of theinsertion set in subcutaneous tissue. However, in alternativeembodiments, the insertion set may be inserted into other subdermaltissues. In addition, still further embodiments may be used to place thesets in other types tissue, such as muscle, lymph, organ tissue or thelike, and used in animal tissue. In preferred embodiments of the presentinvention, the insertion device is loaded with a standard hand-heldinsertion set, or the like, and then placed against the skin of theuser, where the insertion device is activated to transcutaneously placea portion of the insertion set, or the like, subcutaneously in a quickmanner that minimizes pain and/or discomfort to the user. However, itwill be recognized that further embodiments of the invention may be usedto place an entire insertion set, or the like, beneath the skin, ratherthan just a portion of the insertion set. As discussed, preferredembodiments of the insertion device are designed to accommodateoff-the-shelf insertion sets, or the like. But, alternative embodimentsmay be used with customized insertion sets, or the like that have beenaltered to fit the insertion device in a particular orientation orconfiguration to improve safety and/or assure proper placement of theinsertion set, or the like. In still other embodiments, the insertionsets, or the like may be angled and the devices are capable of insertionat angles between 0 and 90 degrees relative to the skin surface afterinsertion of the insertion set.

[0071] In preferred embodiments, the insertion set includes at least onepiercing member to pierce the skin during insertion. In particularembodiments, the piercing member is a metal needle. In alternativeembodiments, the needle may be hollow, solid, half needle (or otherfraction), or the like. In further alternative embodiments, the piercingmember may be made out of other materials, such as ceramic, plastic,composites, silicon micro-needles, biodegradable, hydrophillicsubstances, substances that soften and/or change once in contact withthe body and/or bodily fluids, or the like. In other alternativeembodiments, the insertion set may include more than one piercingmember. For example, a single insertion set may include a piercingmember for an infusion portion and another piercing member for aseparate sensor portion, or the like. Alternatively, the insertion setmay include a plurality of small piercing members on a small patch orsubstrate, such as a series of hollow micro-needles (such as fromsilicon, plastics, metal or the like) for infusion of a medication or aseries of solid micro-needles for sensor applications (such as fromsilicon, plastics, metal or the like), which micro-needles are used topenetrate the skin.

[0072] As shown in the exemplary drawings, an injector (or insertiondevice) in accordance with a first embodiment of the present inventionis referred to generally by the reference numeral 10 is provided forquick and easy transcutaneous placement of a medical needle,particularly such as an insertion needle 12 of the type provided with asubcutaneous insertion set 14 as depicted in FIGS. 4 and 7. The injector10 includes a trigger-type actuator mechanism for transcutaneousplacement of the insertion needle 12 with a controlled speed and force,and with the insertion needle 12 oriented at a desired angular positionrelative to the skin 16 (FIGS. 1 and 9) of the patient.

[0073] The automatic injector 10 of the present invention, as shown inthe illustrative drawings, is particularly designed for placement of theinsertion needle 12 of a subcutaneous insertion set 14, such as aninsertion set of the general type shown and described in U.S. Pat. Nos.4,755,173; 5,176,662; and 5,257,980, which are incorporated by referenceherein. Such insertion sets 14 are used to infuse medical fluids such asselected medications to a patient, with one example being theadministration of insulin to a diabetic by operation of a programmablemedication infusion pump (not shown) of the type described in U.S. Pat.No. 4,685,903. Alternatively, the injector 10 may be used totranscutaneously place a medical needle associated with other types ofinsertion sets, such as transcutaneous sensor insertion sets of thegeneral type shown and described in U.S. Pat. Nos. 5,390,671; 5,560,806and 5,586,553, which are also incorporated by reference herein. Suchinsertion sets are used, for example, to monitoring patient glucoselevels.

[0074] As shown best in FIG. 4 with respect to an insertion set 14 forinfusing medical fluids to a patient, the insertion needle 12 isconnected to a hub 18 at a rear or proximal end thereof, and protrudesthrough a housing 20 of the insertion set 14, wherein the housing 20defines an internal chamber (not shown) for receiving medication viainfusion tubing 22. An enlarged base, typically in the form of resilientor flexible wings 24, is provided on the housing 20 for stableaffixation to the skin 16 of a patient. The insertion needle 12protrudes downwardly through the housing 20 and the winged base 24 toextend through a soft and flexible cannula 26. The insertion needle 12is provided for transcutaneous placement of the cannula 26, after whichthe insertion needle is retracted from the set 14 (FIG. 16) to permitmedication delivery through the cannula 26 to the patient.

[0075] The injector 10 of the present invention represents a simpledevice which can be used by the patient to quickly and easily place thesubcutaneous insertion set 14 in a proper transcutaneous position andorientation, at a selected medication insertion site. The injector 10 isdesigned to project the insertion set toward the patient's skin 16 at acontrolled force and speed for quickly piercing the skin in a mannerinsuring proper placement of the insertion needle 12 and cannula 26,while minimizing patient anxiety and/or discomfort. Improper and/orpartial placement of the insertion needle 12 is thus avoided.

[0076] In general terms, as shown in one preferred form is FIGS. 1-5,the injector 10 comprises a cylindrical forward barrel 28 (or devicehousing) having a plunger 30 (or carrier body) mounted therein forlongitudinal sliding movement within a hollow bore between a forwardadvanced position (FIG. 5) and a rearward retracted position (FIG. 9).The plunger 30 has a head 32 at a forward end thereof for releasiblyreceiving and retaining the subcutaneous insertion set 14, in a mannerto be described in more detail. A rear end of the plunger 30 cooperateswith a trigger-type actuator assembly 34 mounted on the rear end of thebarrel 28. The trigger actuator assembly 34 (or driver) is adapted tohold the plunger 30 in a retracted position, against the force of acompressed drive spring 36. A trigger button 38 of the actuator assembly34 is adapted for fingertip depression to release the plunger 30 forspring-loaded travel toward the advanced position, and correspondingtranscutaneous placement of the insertion needle 12 through thepatient's skin.

[0077] FIGS. 2-5 illustrate construction details of the injector barrel28, wherein the forward or nose end thereof defines a flat and generallyplanar surface for placement against the skin of a patient (FIG. 1) witha longitudinal axis of the barrel 28 oriented generally perpendicular tothe patient's skin 16. The barrel 28 has a size and shape forsubstantially mated sliding fit reception of the infusion set 14, withthe insertion needle 12 and related cannula 26 projecting in a directionfor placement on a patient. In this regard, the nose end of the barrel28 defines an opposed pair of relatively wide and open-ended cut outs 40for slide-fit reception of the oppositely projecting base wings 24. Anarrower slot 42 is also formed in the barrel nose end, at a locationfor slide-fit reception of the infusion tubing 22 attached to theinfusion set 14. Thus, the forward or nose end of the barrel 28accommodates sliding reception of the subcutaneous insertion set 14therein for movement along the cut outs 40 and the slot 42 between theadvanced position (FIG. 5) disposed substantially at the forwardmost endof the barrel 28, and the retracted position (FIG. 9) with the basewings 24 and infusion tubing 22 positioned substantially at the inboardends of the cut outs 40 and the associated slot 42.

[0078] The plunger 30 includes the head 32 of generally cylindricalshape for slide-fit reception within the injector barrel 28. A forwardend of the head 32 includes a cylindrical counterbore recess 44 forreceiving the hub 18 and housing 20 of the insertion set 14, with theenlarged base wings 24 fitted against a pair of outwardly protrudingbackstop flanges 46 adapted for slide-fit reception within the cut outs40 in the barrel nose end. A pair of track arms 48 (FIG. 5) protruderearwardly from the plunger head 32 and include out-turned latch fingers50 for guided reception within longitudinally extending track slots 52formed in the barrel 28 at a location spaced aft from the barrel noseend. These track arms 48 thus cooperate with the barrel track slots 52to guide the plunger 30 between the advanced position (FIGS. 5 and 7)and the retracted position (FIG. 9).

[0079] The plunger 30 also includes a central drive stem 54 (FIG. 5)which protrudes rearwardly from the plunger head 32 within the barrelinterior. The rearward end of the drive stem 54 is longitudinally splitto define a pair of trigger arms 56 which have out-turned triggerfingers 58 on 25 the rearward ends thereof.

[0080] The trigger-type actuator assembly 34 is mounted on the rearwardend of the injector barrel 28, and generally functions to releasiblyretain the plunger 30 in a retracted and cocked position, ready forrapid and spring-loaded actuation upon depression of the trigger button38 to place the insertion set 14 on the patient. More particularly, asshown best in FIGS. 5-9, the trigger assembly 34 comprises a mainsupport cap 60 having a mounting sleeve 62 protruding in a press-fit andpreferably adhesively connected manner into the rear or aft end of theinjector barrel 28. The drive spring 36 comprises a coil springpositioned about the drive stem 54 on the plunger 30 and reacts betweena rearward face 64 of the plunger head 32, and a shoulder 66 on thesupport cap 60. The drive spring 36 normally biases the plunger 30toward the advanced position (FIGS. 5 and 7). However, an insertion set14 seated in the plunger head 32 can be pressed rearwardly against theplunger 30 to move the plunger to the retracted position, as viewed inFIG. 9, with the trigger fingers 58 passed through a conical or taperedlatch bore 68 formed in the support cap 60 to engaging a shoulder 70 onan opposite side of the support cap 60. In this regard, the triggerfingers 58 have ramped outboard faces to accommodate movement of thefingers 58 radially toward each other as they pass through the latchbore 68. When the trigger fingers 58 pass entirely through the bore 68,the spring resilience of the trigger arms 56 is sufficient to spread thetrigger fingers 58 so that they engage the shoulder 70. In thisretracted plunger position, the drive spring 36 is retained in acompressed and cocked condition, with the insertion set 14 including theinsertion needle 12 and related cannula 26 withdrawn into the interiorof the barrel 28, in spaced relation to the patient's skin 16.

[0081] The trigger actuator assembly 34 additionally includes anactuator pin 72 mounted within a noncircular bore 74 (FIGS. 6 and 7)formed in the support cap 60 for longitudinal sliding movement through ashort stroke, relative to the plunger 30. In this regard, the actuatorpin 72 includes one or more noncircular lands 76 for slide-fit receptionwithin the bore 74, to prevent actuator pin rotation therein. Theactuator pin 72 is held within the bore 74 by a stepped lock ring 78which is retained against a rearward end of the support cap 60 by apress-fit outer retainer sleeve 80 having an inturned rim 82 at therearward end thereof Importantly, as shown best in FIG. 8, an oblongland 84 is formed on the actuator pin 72 for mated slide-fit receptionthrough an oblong recess 85 formed in the lock ring 78. A return spring86 (FIG. 7) is carried within the support cap bore 74 and reacts betweenthe shoulder 70 and a nose end of the actuator pin 80 for biasing theactuator pin 80 rearwardly within the support cap.

[0082] The rearmost end of the actuator pin 72 defines the triggerbutton 38. As shown in FIGS. 11 and 13, the trigger button 38 can bedepressed with a fingertip to move the actuator pin 72 through a shortstroke against the return spring 86 in a direction toward the triggerfingers 58 at the rear end of the plunger 30. As shown best in FIG. 13,the actuator pin 72 has a hollowed cylindrical forward tip 88 with adiametric size for engaging and squeezing the trigger fingers 58together at the rear end of the plunger 30, in a manner enabling thosetrigger fingers 58 to pass back through the tapered conical latch bore68. As soon as the trigger fingers 58 thus release from engagement withthe shoulder 70 on the support cap 60, the drive spring 36 translatesthe plunger 30 with the insertion set 14 thereon with a rapid andcontrolled force and speed toward the advanced position, resulting intranscutaneous placement of the needle 12 and cannula 26, as viewed inFIG. 15. Importantly, the spring rate characteristics of the drivespring 36 and the distance of plunger stroke are chosen for asubstantially optimized and proper transcutaneous placement of theneedle 12 and cannula 26, all in a manner which minimizes patientdiscomfort during the needle placement procedure. Moreover, by formingthe nose end of the injector barrel 28 with a squared-off shape asshown, the injector 10 can be easily oriented substantiallyperpendicular to the skin 16 for proper placement of the insertion set.

[0083] Depression of the actuator pin 72 by means of the trigger button38 requires the lock ring 78 to be rotatably oriented in a positionaligning the oblong recess 85 therein with the oblong land 84 on theactuator pin. Accordingly, when these oblong structures are rotationallyaligned (FIGS. 13-14), the injector 10 is armed for trigger buttondepression and corresponding release of the retracted and cockedplunger. However, the lock ring 78 can be rotated relative to theactuator pin 72 to misalign these oblong structures, as shown in FIGS.9-12, whereupon the actuator pin 72 is locked in a rearward positionagainst depression and actuation. A set pin 90 on the lock ring 78 maybe provided and received within an accurate notch 92 formed in theretainer sleeve flange rim 82, to permit lock ring rotationback-and-forth through a part circle increment, on the order of about 90degrees. Appropriate indicia may be applied to the retainer sleeve rim82, such as the letter “L” for “locked” and the letter “A” for “armed”,as viewed in FIGS. 12 and 14, to provide a visual indication of thesetting of the trigger assembly 34.

[0084] In accordance with one aspect of the invention, the plunger head32 additionally includes a safety lock mechanism in the form of a pairof safety lock arms 94 pivotally carried in narrow slots 96 formed inthe plunger head 32. These safety lock arms 94 have rearward endsconnected to the head 30 by pivot pins 98, and forward ends definingcontoured lock fingers 100 which protrude into the plunger head recess44. As shown in FIG. 7, the safety lock arms 94 and their associatedlock fingers 100 have a size and shape so that the fingers 100 canengage and retain the hub 18 of the insertion set 14, for example, byfitting into a recess 101 defined between the hub 18 and housing 20 ofthe insertion set. Importantly, the locations of the lock arm pivotpoints are chosen to insure that the lock arms 94 engage and retain theinsertion set 14 whenever the plunger 30 is moved from the advancedposition (FIG. 7) toward and to the retracted position (FIG. 9). Whenthe plunger 30 reaches the fully advanced position, the safety lock arms94 including their respective pivot pins 98 are disposed within the widecut outs 40 and are therefore free to swing outwardly, relative to theinsertion set 14, to accommodate separation of the insertion set fromthe injector 10 with a substantially minimum separation force. Thisconfiguration has been found to be highly effective as a safeguard toprevent the insertion set 14 from being thrown as a projectile from theinjector 10, in the event that the trigger assembly 34 is activatedwithout prior placement of the injector 10 firmly against the patient'sskin 16. In use, the subcutaneous insertion set 14 can be placed quicklyand easily into the open nose end of the injector barrel 28, within therecess 44 formed in the plunger head 32. Such assembly of the insertionset 14 with the injector 10 requires simple alignment of the base wings24 and infusion tubing 22 with the appropriate cut outs and slots 40, 42formed in the nose end of the barrel 28. The insertion set 14 andplunger 30 can then be manually retracted rearwardly, against the drivespring 36, to the retracted position with the plunger 30 cocked andlatched as viewed in FIGS. 9 and 11. The injector 10 can then be placedfirmly against the patient's skin 16, with the insertion set 14supported in the proper orientation and at a predetermined distance fromthe skin 16. Simple depression of the trigger button 38 releases thecocked plunger 30 for spring-loaded travel rapidly albeit with acontrolled speed and force of insertion, to ensure penetration of thepatient's skin with minimal discomfort, and in a manner which properlyplaces the insertion needle and cannula. The safety lock arms 94 preventaccidental projection of the insertion set 14 through free space, in theevent that the trigger button 38 is prematurely depressed. When theinsertion set 14 is properly placed, however, the safety lock arms 94release from the insertion set with minimal force, for easy separationof the injector 10 from the insertion set 14.

[0085] In preferred embodiments, the controlled speed and force of theinsertion device is obtained by selecting a spring constant of a springto propel and insert the insertion set at the proper speed and force toensure penetration with minimal discomfort. In alternative embodiments,as shown in FIGS. 48a-48 d, there is the need to vary the speed andforce, from one insertion cycle to the next, to accommodate differentinsertion sets (such as finer needles, sensor sets fragility or thelike) and insertion site conditions (such as overweight, underweight,children or the like). As shown in FIG. 48a, a force changing mechanism1000 having a spring 1002 enclosed in a sealed compartment 1004 is usedwith a set (or adjustable) orifice 1006 to allow equalization ofinternal and ambient pressures during the insertion stroke of theinsertion device. The sealed compartment 1004 includes sealing O-rings1008 and 1010 to seal the sealed compartment 1004. The O-ring 1008 sealsthe insertion set carrier body 1012, and the O-ring 1010 seals theactuator housing 1014 (which contains the orifice 1006) of the forcegenerating mechanism 1000. The force changing mechanism 1000 may beactivated by, for example, a trigger 1016 that is biased by a spring1018 to close off the orifice 1006 until depressed. The limiting flowthrough the office 1006 acts as a dampening force, counteracting thespring force from the spring 1002, thereby allowing control of insertionspeed and force. The orifice size can be adjustably attained through anumber of approaches, such as bearing 1020 and spring 1022 that blocksthe orifice 1006 and resists air flow based on the tension of the spring1022 on the bearing 1020 (see FIG. 48b); while presenting a lowerresistance during retraction as the air contained in the sealedcompartment 1004 is compressed, forcing bearing 1020 against spring 1022to unseat the bearing 1022 from the orifice 1006 to present the maximumorifice size for escaping air during compression of spring 1002. Thisstructure minimizes the force needed to compress spring 1022 by allowingair in the sealed compartment 1004 to escape freely and quickly throughthe orifice 1006; rather than be compressed within the sealedcompartment 1004 because the orifice 1006 is restricted by bearing 1002.In another alternative, as shown in FIG. 48c, a disk 1024 has aplurality of various sized holes 1026(1) to 1026(n). The disk 1024 isrotateable over the orifice 1006 to sequentially obstruct, completelyobstruct or partially obstruct the orifice 1006 flow path and changesthe effective size of the orifice 1006 by blocking the orifice 1006 withthe various sized holes 1026(1) through 1026(n). In another embodiment,as shown in FIG. 48d, a tapered valve plug 1028 is threaded intoposition relative to the orifice 1006 to change the effective size ofthe orifice 1006. Other orifice 1006 size changing methods may be used.In addition, other methods of controlling the insertion speed and forcemay be used, such as controlled friction, change in spring tension,hydraulics, pneumatics or the like may be used.

[0086] Following separation of the injector 10 from the placed insertionset 14, the insertion needle 12 can be withdrawn quickly and easily fromthe cannula as viewed in FIG. 16. Thereafter, the insertion set 14 canbe used in a normal manner to deliver a selected medication through theinfusion tubing 22 and cannula 26 to the patient.

[0087] An alternative preferred form of the invention is shown in FIGS.17-29, wherein components corresponding in structure and function tothose described previously with respect to FIGS. 1-16 are identified bycommon reference numerals increased by 100. The embodiment of FIGS.17-29 show a modified injector 110 constructed from a reduced number ofparts and including an alternative safety lock mechanism for preventingundesired projection of the insertion set 14 through free space in theevent of injector operation without placing the nose end thereof firmlyagainst the skin 16 of a patient. However, the alternative safety lockmechanism again permits quick and easy separation of the injector 110from the insertion set 14, with minimal separation force. Once again,although an insertion set for infusing medical fluids to a patient willbe shown and described, it will be understood that alternative insertionsets such as transcutancous sensor insertion sets and the like aspreviously referenced herein may be used with the injector 110.

[0088] In general, the modified injector 110 comprises a plunger 130 anda trigger-type actuator 134 assembled with a generally cylindricalhollow barrel 128. The plunger 130 has a generally cylindrical plungerhead 132 which defines a counterbore recess 144 for receiving andretaining the hub 18 of the infusion set 14. As shown best in FIGS.27-29, a radially inwardly projecting rim 202 is formed on the plungerhead 132 generally at a leading or nose end of the recess 144, whereinthis rim 202 has a noncircular and preferably oval or elliptical shape(FIG. 28) to accommodate reception of the hub 18 into the recess 144provided that the hub 18 is oriented angularly relative to a centrallongitudinal axis of the plunger 130 and barrel 128. Similar angularorientation of these components accommodates quick and easy separationthereof. However, when the insertion set 14 is oriented with the medicalneedle 12 aligned coaxially with the barrel center axis, a portion ofthe rim 202 projects into the insertion set recess 101 to preventrelease of the insertion set 14 from the injector 110.

[0089] More specifically, with reference to FIGS. 17-20, the barrel 128again has a forward or nose end defining a flat and generally planarsurface for firm placement against the skin of a patient. The nose endof the barrel 128 has a pair of relatively wide and generally opposedcut outs 140 formed therein for slide-fit reception of the base wings 24of the insertion set 14, in combination with a narrower slot 142 forslide-fit reception of the infusion tubing 22. This slot 142 may beformed in one or both sides of the barrel nose end.

[0090] The plunger 130 is slidably fitted into the barrel 128 formovement between an advanced position shown in FIGS. 17, 18, 20 and 21,and a retracted position shown in FIG. 23. The plunger 130 includes themodified plunger head 132 of generally cylindrical shape, formedpreferably to include a shallow notch or groove 133 in one side thereoffor slide-fit reception of the infusion tubing 22 on the insertion set14. In this regard, the plunger head groove 133 is formed in a positionaligned with the narrow slot 142 in the nose end of the barrel.

[0091] The plunger head 132 is formed integrally with a drive stem 154which projects rearwardly within the barrel interior. As shown best inFIG. 22, the drive stem 154 is flanked by and formed integrally with apair of rearwardly projecting track arms 148 which have latch fingers150 formed at the rear ends thereof. As shown in FIGS. 21 and 23, theselatch fingers 150 are received slidably within longitudinally extendingtrack slots 152 formed in the barrel 128, and function to guide theplunger 130 between the advanced and retracted positions. Cushioningmaterial (not shown) may be included at the leading ends of the trackslots 152 to form a combined stop upon spring driver advancing motion ofthe plunger 130, as will be described.

[0092] The plunger 130 additionally includes a pair of trigger arms 156which project generally rearwardly from a rear end of the drive stem 154and have out-turned trigger fingers 158 at the rear ends thereof (FIG.22). These trigger fingers 158 are adapted and sized for partial radialcompression toward each other as they ride within the barrel base whenthe plunger 130 is displaced from the advanced position (FIG. 21) to theretracted position (FIG. 23). As the retracted position is reached, thetrigger fingers 158 are spring-loaded by the resiliency of the triggerarms 156 to move outwardly for partial reception into relatively shorttrigger slots 159 formed in the barrel 128. In this position, as shownin FIG. 23, the triggers fingers 158 retain the plunger 130 in theretracted position.

[0093] A drive spring 136 is mounted within the barrel 128 to reactbetween the trigger-type actuator 134 and the plunger 130, in the samemanner as previously described with respect to FIGS. 1-16. In thisregard, the trigger actuator 134 comprises a generally cylindricalactuator sleeve 188 mounted slidably within the barrel 128 at the rearor upper end thereof This actuator sleeve 188 has a tapered or rampedleading edge face 188′ (FIGS. 22, 23 and 25) for engaging matinglyshaped ramped outer faces of the trigger fingers 158, to radiallycompress the trigger arms 156 and release the plunger 130 forspring-loaded travel from the retracted and cocked position to theadvanced position. A trigger button 138 is formed integrally with theactuator sleeve 188 and is exposed for fingertip depression at the rearor top of the barrel 128 to move the actuator sleeve 188 into releasingengagement with the trigger fingers 158.

[0094] As shown best in FIGS. 22 and 24-26, the triggers button 138extends through an opening formed in the rear of the barrel 128,generally within a lock sleeve 178 formed integrally with the barrel128. The lock sleeve 178 defines an oppositely formed pair of guideslots 192 for aligned reception of a pair of outwardly radiating locktabs 184 formed on the trigger button 138. When the tabs 184 androtationally aligned with the guide slots -192, the trigger button 138can be depressed to actuate the spring-locked plunger, as described.However, the lock tabs 184 have sufficient length to permit fingertiprotation of the actuator 134 to re-position the tabs 184 within shallowlock grooves 193 formed adjacent the guide slots 192. When the tabs 184are seated in the lock grooves 193, the lock sleeve 178 blocksdepression of the triggers button 138 and thereby locks the injector 110against actuation. Return rotation of the actuation 134 to re-align thetabs 184 with the guide slots 192 is required before the injector can beactivated.

[0095] In accordance with one aspect of the invention, the plunger head132 includes the safety lock mechanism in the form of the noncircularrim 202 at the leading end of the recess 144 in the plunger head. Asshown in FIGS. 27 and 28, the rim 202 has a generally elliptical shapedefining a major axis that is greater than the diameter of the hub 18 onthe insertion set 14, and a minor axis that is less than the hubdiameter. With this geometry, and by providing sufficient axial depth tothe plunger head recess 144, the hub 18 can be fitted into the plungerhead by angularly orienting the components to permit slide-fit of thehub 18 through the major axis portion of the rim 202. Subsequentre-orientation of the components to align the medical needle 12generally coaxially with plunger head 32 enables the minor axis portionof the rim 202 to project into the insertion set recess 101, therebylocking the components together. Thereafter, when the insertion set 14is placed on the patient (FIG. 29), the components are easily separatedby lifting the injector 110 off the insertion set 14 at the same angleto allow the hub 18 to press freely through the major axis center of therim 202. Importantly, such engagement and disengagement of thecomponents occurs with essentially no resistance force to separation.The infusion set 14 can be oriented angularly relative to the plunger130 only when the plunger is in the advanced position, with the adjacentbarrel 128 precluding such angular orientation when the plunger 130 ismoved rearwardly from the restricted position.

[0096] In an alternative mode of operation, subsequent to actuation ofthe injector 110 to place the insertion set 14 of the patient, theinjector 110 can be simply withdrawn or retracted in a direction awayfrom the patient's skin 16, in which case the rim 202 at the nose end ofthe plunger head 132 will engage the needle hub 18 and thereby gentlywithdraw the medical needle 12 from the insertion set 14, In thismanner, the needle 12 is retracted from the cannula 26 which remains atthe desired transcutaneous insertion site.

[0097] A further alternative preferred form of the invention is shown inFIGS. 30-34, wherein a further modified injector 210 is constructed andoperated generally as shown and described in FIGS. 17-29, but wherein analternative configuration for a plunger head 232 is provided. FIGS.30-32 show the injector 210 with the plunger head 232 in the advancedposition within the front or nose end of the barrel 128 which includesthe wide cut outs 140 and the narrow slot 142 for respective slide-fitreception of the base wings 24 and the tubing 22 of the insertion set14. As shown, the modified plunger head 232 has a laterally open recess244 formed therein of undercut geometry and laterally exposed throughthe cut outs 140 when the plunger is in the advanced position. Theinsertion set 14 can be slide-fit assembled with the plunger head 232,by fitting the hub 18 into the wider upper region of the recess 144,with an inturned rim 302 at the leading end of the plunger head fittinginto the insertion set recess 101. A laterally open gap 303 (FIG. 34) inthe rim 302 permits slide-fit reception of the hub 18 into the recess244, and a short carrier post 304 (FIG. 32) may be provided at the baseof the recess 244 to seat within a shallow detent in the top of the hub.

[0098] With the insertion set 14 assembled with the plunger head 232, asviewed in FIG. 32, the plunger can be retracted and cocked as previouslyshown and described with respect to FIGS. 17-29. The cut outs 140 andslot 142 accommodate sliding movement of the insertion set 14 with theplunger 232 during such retraction. Thereafter, the front or nose end ofthe injector 210 can be placed firmly against the patient's skin (FIG.33) and the trigger button 138 depressed to release the plunger so thatthe medical needle 12 is transcutaneously placed with the controlleddrive force and speed. During forward drive motion of the plunger, theforward rim 302 on the plunger head 232 prevents projectile release ofthe insertion set. After placement of the insertion set on the patient,the injector 210 can be laterally displaced relative to the insertionset for quick and easy separation therefrom. Alternately, as viewed inFIG. 34, the injector 210 can be withdrawn or retracted from theinsertion set 14 to slidably withdraw the medical needle 12 whileleaving the insertion set in place on the patient.

[0099] FIGS. 35-40 g illustrate an insertion device 500 in accordancewith a second embodiment of the present invention. The insertion device500 includes a barrel 502 (or device housing) having a surface seat 501and an assembly port 503, a carrier body 504 (or plunger or the like)having an assembly rim 505 and a seating flange 506, a drive spring 507(or driver), a release button 508, and dual spring triggers 510 and 512.As shown in FIG. 35, the barrel 502 performs as a housing to hold thecarrier body 504. The carrier body 504 is connected to the barrel 502 bythe carrier body being inserted through an opening in the surface seat501 of the barrel 502, and then passing the assembly rim 505 of thecarrier body 504 through the assembly port 503 of the barrel 502. Thesection of the carrier body 504 with the assembly rim 505 compressesslightly, as it passes through the assembly port 503, due to thepresence of compression slots 509, and then essentially restores to itsoriginal shape to prevent the carrier body 504 from sliding out of thebarrel 502, since the assembly rim 505 of the carrier body engages withthe assembly port 503 of the barrel 502.

[0100] The carrier body 504 is driven to an advanced position from aretracted position by the drive spring 507 and held in the retractedposition (or released to move to the advanced position) by the triggerbuttons 510 and 512. This embodiment of the insertion device 500 isprimarily adapted for insertion of insertion sets 400 (as exemplaryshown in FIG. 39 as an infusion set), or the like, that are insertedwith the piercing member 402 (or needle) at 90 degrees (orperpendicular) to the skin surface after insertion. In preferredembodiments, the carrier body 504 is permanently coupled to the barrel502 and new insertion sets 400 are attached to the carrier body 504 foreach new insertion. However, in alternative embodiments, the carrierbody 504 may be a disposable that is replaced after each insertion sothat, for instance, a carrier body 504 may be shipped with apre-installed insertion set 400 and then loaded into the barrel 502 ofthe insertion device 500.

[0101] The insertion device 500 features a low profile compact packagethat tends to minimize the effects of hand movement during insertion ofthe insertion set 400. In this embodiment, the release button 508 isdepressed to release the insertion set 400, or the like, from thecarrier body 504 of the insertion device 500; rather than engaging ordisengaging the insertion set 14 using a lateral slot as shown in FIGS.31-34 above. The release button 508 can be used before or afterinsertion of the insertion set 400, or the like. To facilitate insertionof an insertion set 400, or the like, the insertion device 500 utilizesdual trigger buttons 510 and 512, which provide an extra margin ofsafety and substantially prevents accidental activation of the insertiondevice 500 upon contact with the skin surface. This obviates the needfor a lock and unlock position on the activation buttons (or triggers)of the earlier insertion devices shown in FIGS. 1-34. The insertiondevice 500 also includes another rim on the carrier body 504 that formsthe seating flange 506 to hold a rim 404 (or wing) of the insertion set400, or the like, that carries an adhesive 406 for adhering theinsertion set 400 to the surface of the skin. Upon activation of theinsertion device 500 to move the carrier body to the advanced position,the seating flange 506 presses the adhesive 406 and rim 404 of theinsertion set 400 firmly against the skin surface to provide positiveseating and attachment of the insertion set 400 to the skin. This maymake it unnecessary to require placement of an additional adhesive patchprior to or after inserting an insertion set 400 to secure the insertionset 400 at the insertion site. The insertion device 500 further includesan automatic release of the piercing member (or needle) hub 408 andpiercing member 402 (or needle) from the insertion set 400, or the like,after the insertion set 400, or the like, has been inserted. Thispermits the insertion set 400 to be left on the skin surface without thepiercing member hub 408 and piercing member 402 (or needle) remaining bysimply removing the insertion device 500 from the skin surface. Thisautomatic release feature also minimizes potential patient contact withthe piercing member 402 (or needle) of the insertion set 400, or thelike.

[0102] In preferred embodiments, the insertion set 400, or the like, isadapted to tightly fit within a cavity 514 (or receiving structure) ofthe carrier body 504. The cavity 514 of the carrier body 504 includesguides 516 to orient the insertion set in a particular orientation andan expansion member 518 in the center bottom interior of the cavity 514of the carrier body 504 to engage with the piercing member hub 408 (orneedle hub) of the insertion set 400, or the like. The piercing memberhub 408 of the insertion set 400, or the like, includes a center section410 that engages with the expansion member 518 with a slightinterference fit. The interference fit expands the center-section 410 ofthe piercing member hub 408 slightly to expand and press the piercingmember hub 408 against the sides of the cavity 514 of the carrier body504 to firmly secure the insertion set 400, or the like, within thecavity 514 of the carrier body 504. The tight fit of the insertion set400,or the like, in the carrier body 504 substantially prevents theinsertion set 400, or the like, from being dislodged when the insertiondevice 500 is activated to improve insertion of the insertion set 400,or the like, on the skin. However, the tight fit also prevents theinsertion set 400, or the like, from being ejected if the insertiondevice 500 is inadvertently activated When it is not pressed against theskin surface. In preferred embodiments, the insertion device 500 isconfigured to have guides 516 and an expansion member 518 to work withexisting insertion sets 400, or the like. However, in alternativeembodiments, the insertion set 400, or the like, may be modified to havea piercing member base, housing or the like that includes slots (notshown) for receiving guides and expanding members of the insertiondevice 500 to improve the connection between the insertion device 500and the insertion set 400, or the like. In further alternativeembodiments, the guides and expansion members may be formed on theinsertion set 400, or the like, and the corresponding guide slots andexpanding sections may be formed on the insertion device 500.

[0103] The illustrated embodiment employs a dual trigger activationstructure to minimize the ability of the insertion device 500 to beunintentionally activated. As illustrated, the barrel 502 of theinsertion device 500 includes two outwardly extending guide channels 520and 522 on the side of the barrel 502. The guide channels 520 and 522extend from the base 524 of the barrel 502 up to portal openings 526 and528 in the side of the barrel 502. The dual trigger buttons 510 and 512are carried on opposite sides of the seating flange 506 at the end ofthe carrier body 504. Each trigger button 510 and 512 is biased outwardfrom the side of the seating flange 506 by a trigger spring 530 and 532between the end of the trigger buttons 510 and 512 and the side of theseating flange 506. When the carrier body 504 of the insertion device500 is locked in the firing position (or retracted position), thetrigger buttons 510 and 512 are pushed out by the trigger springs 530and 532 to extend out of the portal openings 526 and 528. In thisposition, the trigger buttons 510 and 512 extend beyond the bottom ofthe guide channels 520 and 522, which prevents the trigger buttons 510and 512 from moving down the guide channels 520 and 522. To activate theinsertion device 500, the user must depress both trigger buttons 510 and512 so that the trigger buttons 510 and 512 can then slide along thebottom of the guide channels 520 and 522, which in turn allows thecarrier body 504 to move down along the barrel 502 until the insertionset 400, or the like, is inserted. In preferred embodiments, the portalopenings 526 and 528 and the end of the guide channels 520 and 522terminating at the portal openings 526 and 528 are rounded to match theshape of the trigger buttons 510 and 512. This tends to minimize theresisting pressure on the trigger buttons 510 and 512 during depressionof the trigger buttons 510 and 512. However, in alternative embodimentsother portal opening and guide channel end shapes, such as beveled,squared, polygonal, or the like, may be used.

[0104] The end of the carrier body 504 having the assembly rim 505 isconnected to a release button 508 that can be depressed or slightlyextended relative to the carrier body 504. The release button 508includes engagement tabs 550 and lock teeth 552 (see FIGS. 35 and 36)that engage with carrier slots 554 and carrier locks 556 (see FIGS. 36and 38) to lock the release button 508 to the carrier body 504. The lockteeth 552 engage with the carrier locks 556 (see FIGS. 36 and 38) topermit an amount of movement of the lock teeth 552 along the carrierlocks 556 to allow the release button 508 to be depressed to release aninsertion set from the carrier body 504. The release button 508 is alsoslightly extended away from the carrier body 504 when an insertion set400 is placed in the interior cavity 514 of the carrier body 504 topermit seating of the insertion set 400. Engaging the release button 508with the carrier body substantially prevents the compression slots 509and assembly rim 505 from compression and inhibits release of thecarrier body 504 from the barrel 502 of the insertion device 500.

[0105] The release button 508 is depressed to release the insertion set400, or the like, from the carrier body 504 of the insertion device 500.The release button 508 pushes the insertion set 400, or the like, out ofthe cavity 514 of the carrier body 504 sufficiently enough to releasethe insertion set 400, or the like, from the guides 516 and theexpanding member 518 in the cavity 514 and leave the inserted insertionset 400, or the like, on the skin. Alternatively, the release button 508may be activated to release an insertion set 400, or the like, from thecarrier body 504 prior to the insertion set 400, or the like, beinginserted by the insertion device 500. The release button 508 alsoincludes a ramp portion 534 (or other trigger mechanism) that is adaptedto bend or adjust the piercing member hub 408 (or needle hub) of theinsertion set 400, or the like, to allow the piercing member hub 408 andpiercing member 402 (or needle) to be released and separated from theinsertion set 400, or the like, when the insertion set 400, or the like,has been inserted and the insertion device 500 is lifted off the skin.This can be accomplished by separating the elements of the insertion set400, or the like, so that only the insertion set, or the like, housingand tubing (or wiring or the like) are left in contact with the skin.The ability to remove the piercing member hub 408 and piercing member402 is preferably facilitated by the adhesive 406 of the insertion set400, or the like, that attaches to the skin to provide sufficienttension to allow for separation of the piercing member hub 408 and thepiercing member 402 from the rest of the insertion set 400, or the like,without dislodging the insertion set 400, or the like. In preferredembodiments, the insertion device 500 is adapted to work with anexisting piercing member hub 408 on an insertion set 400, or the like.However, in alternative embodiments, the piercing member hub 408 and theconnection between the piercing member hub 408 and the insertion sethousing, or the like, is modified to work with the release mechanism ofthe insertion device 500.

[0106] In preferred embodiments, the release button 508 is biased inposition by a plastic or metal spring. However, in alternativeembodiments, the release button 508 may be manually reset by engagingand disengaging detents or using other elastomeric materials to bias therelease button 508 in position relative to the barrel 502 and thecarrier body 504. In preferred embodiments, pulling up the releasebutton 508 (or extending it away from the assembly port 503 of thebarrel 502) pulls the carrier body 504 to the retracted position in thebarrel 502, where it is locked in place by triggers 510 and 512 engagingthe portal openings 526 and 528. This procedure separates the piercingmember hub 408 and piercing member 402 from the housing of the insertionset 400, or the like. This has the advantage of removing the piercingmember 402 and piercing member hub 408 to minimize the opportunity of auser being stuck by the piercing member 402.

[0107]FIGS. 40a-40 g illustrate one method of insertion of an insertionset 400 with the insertion device 500 in accordance with an embodimentof the present invention. The user first cleans and sterilizes aninsertion site on the skin. Next, the user makes sure the insertiondevice 500 has the carrier body 504 in the advanced position to avoidunintentional activation of the insertion device 500 before placement onthe skin. As shown in FIG. 40a, the user places the insertion set 400 inthe cavity 514 of the carrier body by aligning the tubing (or wire leadsor the like) with the slot 536 in the carrier body 504 and the slot 538in the barrel 502 of the insertion device 500. The user presses againstthe piercing member guard 414 (or needle guard) to seat the piercingmember hub 408 (or needle hub) and the insertion set 400 in the cavity514 of the carrier body 504. As shown in FIG. 40b, the user removes theadhesive backing 416 covering the adhesive 406 on the rim 404 of theinsertion set 400. It is preferred that the piercing member guard 414 isnot removed at this point to avoid unintentional sticks by the piercingmember 402, and minimize or avoid contact with the adhesive 406. Asshown in FIG. 40c, the user presses against the piercing member guard414 to move the carrier body 504 from the advance position to theretracted position, at which point the trigger buttons 510 and 512 willextend out of the portal openings 526 and 528 to extend beyond the guidechannels 520 and 522 to lock the carrier body 504 in the retractedposition. Next, as shown in FIG. 40d, the user removes the piercingmember guard 414 (normally by twisting) to expose the piercing member402 while maintaining the insertion set 400 within the carrier body 504.Then, as shown in FIG. 40e, the user places the surface seat 501 of thebarrel 502 of the insertion device 500 with the insertion set 400 overthe insertion site on the skin. The user depresses the two triggerbuttons 510 and 512 through the portal openings 526 and 528 sufficientlyfor the trigger buttons 510 and 512 to slide down along the guidechannels 520 and 522 to insert and install the insertion set 400 at theinsertion site on the skin. As shown in FIG. 40f, the user depresses therelease button, 508 to release the insertion set from the cavity 514 ofthe carrier body 504. Finally, as shown in FIG. 40g, the user removesthe insertion device 500, while maintaining installation of theinsertion set 400. In alternative embodiments, the user may extend therelease button 508 to lift off the piercing member hub 408 and piercingmember 402, and maintain the remainder of the insertion set 400 at theinsertion site on the skin. If the piercing member hub 408 and piercingmember 402 are lifted off the device, the user should re-install thepiercing member guard 414 prior to removal of the remaining set from theinsertion device 500.

[0108] FIGS. 41-46 illustrate an insertion device 600 in accordance witha third embodiment that is similar to the insertion devices shown inFIGS. 1-34. The insertion device 600 includes a device housing end 601and a carrier body 602 that has angled insertion contact surfaces 603and 604. The angled insertion contact surfaces 603 and 604 enable theuser to properly angle the insertion device 600 to insert an insertionset 700, or the like, at the proper insertion angle relative to theskin. An insertion set similar to the insertion set 700 is disclosed inU.S. patent application Ser. No. 08/871,831 (PCT Application Serial No.US98/10832) to Van Antwerp et al. entitled “Disposable Sensor InsertionAssembly” or an insertion set that can be inserted at an angle asdisclosed in U.S. patent application Ser. No. 09/034,626 to Funderburket al. entitled “Medication Infusion Set”, both or which are hereinincorporated by reference. Preferred embodiments of the insertion device600 have angled insertion contact surfaces 603 and 604 that permitinsertion of insertion sets, or the like, that are angled from 89.9degrees to 25 degrees relative to the skin surface. In furtherembodiments, the angled insertion contact surfaces 603 and 604 mayhandle even shallower angles down to approximately 10 degrees relativeto the skin surface.

[0109] The key is the angled insertion contact surfaces 603 and 604mirrors the insertion angle of the insertion set 700, or the like, sothat the piercing member 702 (or needle) of the insertion set 700, orthe like, is in axial alignment in the direction of movement of thecarrier body 602 of the insertion device 600. This permits an insertiondevice designed primarily for use with a 90 degree insertion set, or thelike, to be modified to work with angled insertion sets 700, or thelike, by modification of the angle of the angled insertion contactsurfaces 603 and 604. In addition, it is preferred that the piercingmember 702 of the insertion set 700, or the like, be slightly off-centerfrom the center axis of the carrier body 602 to permit easy removal ofthe insertion device 600 once the insertion set 700, or the like, hasbeen inserted. Preferred embodiments of the present invention include acarrier body 602 with a receiving structure that includes a recess 606and bore 608 on one side of the carrier body 602. The recess 606 isadapted to hold the piercing member hub 704 by a slight interference fitand the bore 608 is adapted to hold the insertion tubing or transmitterhub 706 of the insertion set 700, or the like. In other embodiments forthe insertion sets such as infusion sets with tubing (or sensor setswith wire leads already connected to a sensor) the bore 608 may be openon one side (not shown) to permit insertion and removal of the infusiontubing (or wire leads), but closed of sufficiently to securely hold andgrasp the insertion tubing or transmitter hub 706 that connects thetubing or wire leads to the housing of the insertion set 700, or thelike.

[0110]FIG. 47 illustrates an insertion device 800 that is adapted forinserting insertion sets, or the 15 like, at angles that are generallyless than or equal to 10 degrees relative to the skin surface afterinsertion of the insertion set, or the like. This embodiment includes apair of pinchers 802 and 804 that grasps the skin. The pinchers 802 and804 pinches (or bunches) up the skin in front of a carrier body 806holding an insertion set, or the like. Once the skin is pinched (orbunched up), the user depresses an activation button and the insertionset, or the like, is inserted into the skin. In alternative embodiments,the user presses the pinchers 802 and 804 closer together to activatethe insertion device 800. After insertion, the user releases thepinchers 802 and 804 and removes the insertion device 800 from theinsertion set, or the like. The effect of this embodiment is to raisethe skin so that the actual insertion angle of the piercing memberrelative to the side of the raised (or pinched) area of skin ranges from10 degrees to 90 degrees so that the piercing member is inserted inmanner similar to the embodiments described above. However, when thepinched skin is released, the piercing member is left in the skin at ashallow angle between 0 and 10 degrees. The amount of pinching and theheight of the pinch must be carefully controlled to assure that theinsertion set, or the like, is inserted at the proper depth and locationin the skin tissue. One example of an insertion set that can be insertedat an angle as disclosed in U.S. patent application Ser. No. 09/034,626to Funderburk et al. entitled “Medication Infusion Set”, which is hereinincorporated by reference.

[0111] While the description above refers to particular embodiments ofthe present invention, it will be understood that many modifications maybe made without departing from the spirit thereof. The accompanyingclaims are intended to cover such modifications as would fall within thetrue scope and spirit of the present invention.

[0112] The presently disclosed embodiments are therefore to beconsidered in all respects as illustrative and not restrictive, thescope of the invention being indicated by the appended claims, ratherthan the foregoing description, and all changes which come within themeaning and range of equivalency of the claims are therefore intended tobe embraced therein.

What is claimed is:
 1. An insertion device for inserting at least aportion of at least one piercing member of an insertion set through theskin of a patient, the insertion device comprising: a device housing; acarrier body slidably received within the device housing for movementbetween an advanced position and a retracted position, the carrier bodyincluding a receiving structure to support the insertion set in aposition with the at least one piercing member oriented for insertionthrough the skin of the patient at a predetermined angle relative to theskin of the patient upon movement of the carrier body from the retractedposition to the advanced position; and a driver operatively coupledbetween the device housing and the carrier body that urges the carrierbody with a controlled force and speed from the retracted positiontoward the advanced position to place at least a portion of the at leastone piercing member of the insertion set thorough the skin of thepatient to install the insertion set to the patient, wherein thereceiving structure of the carrier body is removable from the insertionset while maintaining the installation of the insertion set to thepatient.
 2. An insertion device according to claim 1, wherein thepredetermined angle relative to the skin is about 90 degrees.
 3. Aninsertion device according to claim 1, wherein the predetermined anglerelative to the skin is between 90 degrees and 10 degrees.
 4. Aninsertion device according to claim 1, wherein the predetermined anglerelative to the skin after insertion is between 0 and 10 degrees.
 5. Aninsertion device according to claim 1, wherein the insertion set is atransuctaneous insertion set.
 6. An insertion device according to claim1, wherein the insertion set is a subcutaneous insertion set.
 7. Aninsertion device according to claim 1, wherein the insertion set restsmainly on the surface of the skin after insertion.
 8. An insertiondevice according to claim 1, wherein the insertion set is fullyimplanted in the skin of the patient.
 9. An insertion device accordingto claim 1, wherein the at least one piercing member is a needle.
 10. Aninsertion device according to claim 1, wherein the at least one piercingmember is a plurality of needles.
 11. An insertion device according toclaim 10, wherein the plurality of needles are micro-needles.
 12. Aninsertion device according to claim 1, wherein the insertion set is aninfusion set.
 13. An insertion device according to claim 1, wherein theinsertion set is a sensor set.
 14. An insertion device according toclaim 1, wherein the device housing has a forward end defining agenerally planar angled insertion contact surface for placement againstthe skin of a patient with the device housing in a predeterminedorientation relative to the patient's skin that mirrors thepredetermined angle of the insertion set relative to the skin of thepatient.
 15. An insertion device according to claim 1, further includinga trigger mechanism that actuates the driver.
 16. An insertion deviceaccording to claim 15, wherein the trigger mechanism includes at leastone trigger for fingertip depression to actuate the driver for movementof the carrier body from the retracted position to the advancedposition.
 17. An insertion device according to claim 1, wherein thedriver includes at least one spring for spring-loaded movement of thecarrier body from the retracted position to the advanced position. 18.An insertion device according to claim 1, wherein the driver includes aforce changing mechanism that permits alteration of the controlled forceand speed of the carrier body moving from the retracted position to theadvanced position from one insertion cycle to another insertion cycle.19. An insertion device according to claim 1, wherein the device housingand the carrier body include a cooperatively engageable track mechanismfor guiding movement of the carrier body between the advanced andretracted positions while retaining the carrier body against rotationrelative to the device housing.
 20. An insertion device according toclaim 1, wherein the at least one piercing member is provided with apiercing member hub as part of the insertion set, and further whereinthe receiving structure of the carrier body includes a recess formedtherein for mated slide-fit reception of the piercing member hub of theinsertion set.
 21. An insertion device according to claim 19, whereinthe recess of the receiving structure includes a laterally open undercutrecess.
 22. An insertion device according to claim 19, wherein thereceiving structure further includes a safety retainer structure thatretains the at least one piercing member on the receiving structureduring movement from the retracted position to the advanced position,the safety retainer structure permits separation of the at least onepiercing member from the carrier body when the carrier body is in theadvanced position.
 23. An insertion device according to claim 1, whereinthe insertion set is both an infusion set and a sensor set combined intoan integral unit.
 24. An insertion set for insertion through the skin ofa patient by an insertion device having a slidable carrier body formovement between an advanced position and a retracted position, thecarrier body of the insertion device including a receiving structure tosupport the insertion set in a position for insertion through the skinof the patient upon movement of the carrier body from the retractedposition to the advanced position, and the insertion device having adriver operatively coupled to the carrier body that urges the carrierbody with a controlled force and speed from the retracted positiontoward the advanced position for insertion of the insertion set thoroughthe skin of the patient, the insertion set comprising: at least onepiercing member, wherein at least a portion of the at least one piercingmember is insertable through the skin of the patient; and a set housingcoupled to the at least one piercing member, wherein the set housing isshaped to fit within the carrier body of the insertion device to orientthe at least one piercing member for placement through the skin of thepatient of at least a portion of the at least one piercing member at apredetermined angle relative to the skin of the patient to install theinsertion set to the patient, and wherein the set housing of theinsertion set is removable from the receiving structure of the carrierbody while maintaining the installation of the insertion set to thepatient.
 25. An insertion set according to claim 24, wherein thepredetermined angle relative to the skin is about 90 degrees.
 26. Aninsertion set according to claim 24, wherein the predetermined anglerelative to the skin is between 90 degrees and 10 degrees.
 27. Aninsertion set according to claim 24, wherein the predetermined anglerelative to the skin after insertion is between 0 and 10 degrees.
 28. Aninsertion set according to claim 24, wherein the insertion set is atransuctaneous insertion set.
 29. An insertion set according to claim24, wherein the insertion set is a subcutaneous insertion set.
 30. Aninsertion set according to claim 24, wherein the insertion set restsmainly on the surface of the skin after insertion.
 31. An insertion setaccording to claim 24, wherein the insertion set is fully implanted inthe skin of the patient.
 32. An insertion set according to claim 24,wherein the at least one piercing member is a needle.
 33. An insertionset according to claim 24, wherein the at least one piercing member is aplurality of needles.
 34. An insertion set according to claim 33,wherein the plurality of needles are micro-needles.
 35. An insertion setaccording to claim 24, wherein the insertion set is an infusion set. 36.An insertion set according to claim 24, wherein the insertion set is asensor set.
 37. An insertion set according to claim 24, wherein theinsertion set is both an infusion set and a sensor set combined into anintegral unit.